Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx
Locoregionally advanced squamous cell carcinoma of the head and neck(LA-SCCHN) poses one of
the most complex management challenges. This stage of disease is still potentially curable,
but requires combined-modality therapy. Recent studies have showed that induction
chemotherapy（neoadjuvant）reduced the 3-year distant relapse rate. Concurrent
chemoradiotherapy(CCRT), on the other hand, has demonstrated a significant and consistent
benefit in local control rates, but its impact on distant failure is inconsistent.
Nimotuzumab is a novel EGFR-targeting monoclonal antibody that has the potential.to be used
as a single agent or as a radio- and chemotherapy sensitizer for the treatment of SCCHN.
Thus, investigators conducted a randomized, multicenter phaseⅡ study to compare the
efficiency and safety of adding nimotuzumab to neoadjuvant and CCRT with neoadjuvant and
CCRT in the treatment of patients with locoregionally advanced squamous cell carcinoma of
the oropharynx and hypopharynx.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.
3 months after all the treatment ending
Yi J Lang, M.D.
China: Food and Drug Administration